Scientist - Pennsylvania, United States - Astrix

Description

Responsibilities:

• Coordinate global COA/PRO strategic plans to support Early Development Teams (EDTs), Clinical Trial Teams (CTT), and Clinical Sub-teams (CST) for alignment with product franchise goals
• Assist in selecting or developing COA/PRO instruments for studies
• Guide the implementation of COA/PRO instruments in studies through standard processes
• Align the selection of suitable endpoint measures to meet regulatory and reimbursement requirements
• Manage COA/PRO sections of evidence packages for submission to regulatory and reimbursement agencies
• Develop, validate, implement, and utilize instruments for measuring COA/PROs in clinical trials or observational studies
• Conduct literature searches to support COA/PRO endpoint strategies
• Produce scientific communications such as abstracts, poster presentations, and manuscripts
• Stay updated on COA/PRO methodologies, guidelines, and communicate findings to study teams

Qualifications:

• PhD (+3 yrs), MS (+5 yrs), or BS (+10 yrs) in Health Services Research, Statistics, Psychometrics, Outcomes Research or related field with industry experience in the COA field
• Familiar with COA/PRO requirements for regulatory and reimbursement agencies
• Knowledgeable in methodological approaches, study design, data analysis, and interpretation related to COA/PRO development
• Ability to engage with internal and external customers effectively
• Strong project management and communication skills
• Experience in COA/PRO-related scientific presentations and publications

Type: Contract (2 years)

Location: Montgomery County, PA (Hybrid)

Pay: up to $58.68/hr